Investigating a new medication for treating ulcerative colitis
A PHASE 1B, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MILD TO SEVERE ULCERATIVE COLITIS
This study is testing a new medication for ulcerative colitis to see if it is safe and effective for adults with different levels of the condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 17 sites (Kissimmee, Florida and 16 other locations) |
| Trial ID | NCT05549323 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, effectiveness, and pharmacokinetics of an experimental medication called PF-07054894 in adults diagnosed with ulcerative colitis. Participants will be divided into two groups based on the severity of their condition, with specific criteria for inclusion based on their disease status and previous treatment responses. The study will involve administering the medication or a placebo and monitoring the participants for any effects and how the body processes the medication.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate to severe or mild to moderate ulcerative colitis who have not responded adequately to previous treatments.
Not a fit: Patients with other forms of colitis, recent bowel surgery, or certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from ulcerative colitis.
How similar studies have performed: Other studies have shown promise in developing new treatments for ulcerative colitis, but this specific medication approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline. * Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy). Part A (moderate to severe): Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2. Part B (mild to moderate): Participants with mMS of 4 to 6, ES of ≥2 and RB score of ≥1 * Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC. * Total body weight \>40 kg (88.2 lb). Exclusion Criteria: * Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer. * History of bowel surgery within 6 months prior to baseline. * History of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study. * Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia. * Clinically significant infections within 6 months of baseline
Where this trial is running
Kissimmee, Florida and 16 other locations
- IHS Health Research — Kissimmee, Florida, United States (Active_not_recruiting)
- Kissimmee Endosocpy Center ( Endoscopy Only ) — Kissimmee, Florida, United States (Active_not_recruiting)
- Orlando Diagnostic Center ( CXR Only ) — Kissimmee, Florida, United States (Active_not_recruiting)
- GCP Clinical Research — Tampa, Florida, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Carta - Clinical Associates In Research Therapeutics Of America — San Antonio, Texas, United States (Active_not_recruiting)
- Charité Research Organisation — Berlin, Germany (Recruiting)
- Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin, Germany (Recruiting)
- NZOZ Centrum Medyczne KERmed — Bydgoszcz, Kujawsko-pomorskie, Poland (Active_not_recruiting)
- Endoterapia PFG SP. Z O. O. — Warsaw, Mazowieckie, Poland (Recruiting)
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Mazowieckie, Poland (Recruiting)
- SP ZOZ Szpital Uniwersytecki w Krakowie — Kraków, Małopolskie, Poland (Recruiting)
- KLIMED Marek Klimkiewicz — Bialystok, Podlaskie, Poland (Recruiting)
- NZOZ Twoje Zdrowie EL Sp. z o. o. — Elblag, Warmińsko-mazurskie, Poland (Active_not_recruiting)
- Centrum Medyczne Med-Gastr — Lodz, Poland (Active_not_recruiting)
- Irmed — Piotrkow Trybunalski, Łódzkie, Poland (Recruiting)
- MZ Badania Slowik Zymla Spolka Jawna — Knurów, Śląskie, Poland (Active_not_recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.